510(k) · Cleared
Recalled · Class II · 2019Ferr Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Chemistry Systems, Inc. · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Cleared on Jan 24, 1997 after a 143-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 24, 1997
- Review
- 143 days
- Class
- Class II
- Product code
- JMG
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK963498 Ferr Flex Reagent CartridgeDade Chemistry Systems, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK112999 Dimension Clinical Chemistry SystemSiemens Healthcare Diagnostics · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK070552 Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)Dade Behring, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963498 | Ferr Flex Reagent Cartridge | Dade Chemistry Systems, Inc. | 1997 | — |
| +1 | K112999 | Dimension Clinical Chemistry System | Siemens Healthcare Diagnostics | 2011 | 7 |
| +1 | K070552 | Dimension Vista Ferritin Flex Reagent Cartridge (Ferr) | Dade Behring, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JMG device
- #1 K234052 Access Ferritinscore 7.3 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Abbott Laboratories IMx® Ferritin Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2019 | Class II | Z-2229-2019 | Under Investigation by firm | Negative Bias with Lot EA9227. |
| Jul 15, 2014 | Class II | Z-2238-2014 | Material/Component Contamination | Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating… |
| May 6, 2013 | Class II | Z-0561-2014 | Software design | Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112999 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JMG devicesJMG Radioimmunoassay (Two-Site Solid Phase), Ferritin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JMG
Too few JMG 510(k)s in any year since 2007 to give a median.
Recalls per year · JMG
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMG
12in 2025
MAUDE reports naming product code JMG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 12 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 0 | — | 1 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FERR Flex™ reagent cartridge is used on the Dimension™ RxL. clinical chemistry system to quantitatively measure ferritin in human serum and plasma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963498: Ferr Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963498
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026